System and method for automating verification of medical instrument sterilization compatibility and sterilization cycle selection

ABSTRACT

A sterilization system includes a communication hub that is configured to transfer information between devices of the system such as a sterilizing cabinet, biological indicator analyzer, and a server in order to allow a user to track a medical device throughout a sterilization process. The server may provide data to the sterilizing cabinet during a sterilization process that may be used to verify that the medical device is compatible with the sterilizing cabinet, and to automatically select a compatible sterilization cycle to perform on the medical device. Automatic selection of sterilization cycles and confirmation of compatibility reduces the possibility for user error, which could result in contaminated medical devices being placed back into service. Automatic selection of sterilization cycles also allows users to more efficiently configure and perform sterilization cycles while being confident that the medical device will be sterile upon completion.

BACKGROUND

Re-usable medical devices such as certain surgical instruments,endoscopes, etc., may be sterilized before re-use to minimize thelikelihood that a contaminated device might be used on a patient.Various sterilization techniques may be employed, such as steam,hydrogen peroxide, and vapor phase sterilization, either with or withouta gas plasma and ethylene oxide (EtO).

Sterilization of medical devices may be performed with an automatedsterilization system such as a STERRAD® System by Advanced SterilizationProducts of Irvine, Calif. Examples of automated sterilization systemsare described in U.S. Pat. No. 6,939,519, entitled “Power System forSterilization Systems Employing Low Frequency Plasma,” issued Sep. 6,2005, the disclosure of which is incorporated by reference herein; U.S.Pat. No. 6,852,279, entitled “Sterilization with Temperature-ControlledDiffusion Path,” issued Feb. 8, 2005, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,852,277, entitled“Sterilization System Employing a Switching Module Adapter to Pulsatethe Low Frequency Power Applied to a Plasma,” issued Feb. 8, 2005, thedisclosure of which is incorporated by reference herein; and U.S. Pat.No. 6,447,719, entitled “Power System for Sterilization SystemsEmploying Low Frequency Plasma,” issued Sep. 10, 2002, the disclosure ofwhich is incorporated by reference herein. Each different medical devicemay require a different arrangement and sterilization process.

While a variety of systems and methods have been made and used formedical device sterilization, it is believed that no one prior to theinventor(s) has made or used the technology as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a schematic view of an exemplary sterilization system;

FIG. 2 depicts a schematic view of an exemplary sterilizing cabinet thatmay be used with the system of FIG. 1;

FIG. 3 depicts a high-level flowchart of an exemplary set of steps thata sterilizing cabinet of FIG. 2 could perform to sterilize a medicaldevice;

FIG. 4 depicts an exemplary set of steps that may be performed by asterilization system such as that shown in FIG. 1 to automaticallyidentify a medical device;

FIG. 5 depicts an exemplary set of steps that may be performed by asterilization system such as that shown in FIG. 1 to track medicaldevices throughout their lifecycle;

FIG. 6 depicts an exemplary set of steps that may be performed by asterilization system such as that shown in FIG. 1 to automaticallyverify the compatibility of a medical device with one or more componentsof the system;

FIG. 7 depicts an exemplary interface for viewing compatibilityinformation for a device in a sterilization cycle;

FIG. 8 depicts an exemplary interface for viewing compatibilityinformation for multiple devices in a sterilization cycle;

FIG. 9 depicts an exemplary interface for viewing a historic record ofsterilization cycles and medical device compatibility;

FIG. 10 depicts an exemplary interface for configuring one or morealerts associated with incompatible sterilization cycles;

FIG. 11 depicts an exemplary interface for choosing devices based upontheir compatibility with a medical device;

FIG. 12 depicts an exemplary interface for viewing compatibilityinformation for all devices currently in use;

FIG. 13 depicts an exemplary interface for viewing an overallcompatibility level; and

FIG. 14 depicts an exemplary set of steps that may be performed by asterilization system such as that shown in FIG. 1 to automaticallyselect and configure an appropriate sterilization cycle for a device.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those skilled in the art in view of the teachingsherein. Such modifications and variations are intended to be includedwithin the scope of the claims.

I. Overview of Exemplary Sterilization System

FIG. 1 depicts a schematic view of an exemplary system (10) ofinterconnected devices that may be configured to perform methodsassociated with sterilizing medical devices (e.g., endoscopes and othermedical devices). System (10) of this example includes a sterilizingcabinet (100), a biological indicator analyzer (102), a communicationhub (20), a server (106), a user device (108), and a sterility guidedatabase (110). Communication hub (20) is configured to providetransmission of data between sterilizing cabinet (100), biologicalindicator analyzer (102), communication hub (20), server (106), userdevice (108), and sterility guide database (110), as will be describedin greater detail below.

FIG. 2 depicts an exemplary set of components that may be incorporatedinto sterilizing cabinet (100). Sterilizing cabinet (100) may beconfigured to perform one or more sterilization cycles, with differentsterilization cycles being appropriate for different types andquantities of medical devices. Sterilizing cabinet (100) of the presentexample includes a sterilization chamber (152), which is configured toreceive one or more medical devices for sterilization. Sterilizingcabinet (100) also includes a sterilization module (156) that isoperable to receive sterilant cartridges (158) and dispense a sterilantfrom a cartridge (158) into sterilization chamber (152). Sterilizingcabinet (100) further includes a touch screen display (160), which isoperable to render various user interface display screens and receiveuser input in the form of the user contacting touch screen display(160). Sterilizing cabinet (100) may include various other kinds of userinput features, including but not limited to buttons, keypads,keyboards, a mouse, a trackball, etc.

Sterilizing cabinet (100) of the present example further includes aprocessor (162), a communication module (164), a reader (166), and amemory (168). Processor (162) is in communication with the variouscomponents of sterilizing cabinet (100) and is operable to process dataand execute control algorithms to drive various components ofsterilizing cabinet (100). Communication module (164) is configured toenable bidirectional communication between sterilizing cabinet (100) andcommunication hub (20). Communication module (164) may also beconfigured to enable bidirectional communication between sterilizingcabinet (100) and server (106) and/or sterility guide database (110).Reader (166) is operable to read an identification tag of a biologicalindicator and/or other devices as described herein. Memory (168) isoperable to store control logic and instructions and that are executedby processor (162) to drive components of sterilizing cabinet (100).Memory (168) may also be used to store results associated with setup ofa sterilization cycle, performance of a load conditioning cycle,performance of a sterilization cycle, and/or various other kinds ofinformation. Various suitable components and configurations that may beused to form processor (162), communication module (164), reader (166),and memory (168) will be apparent to those skilled in the art in view ofthe teachings herein.

In addition to the foregoing, sterilizing cabinet (100) may beconfigured and operable in accordance with at least some of theteachings of any of the patent references previously cited herein; U.S.Pub. No. 2017/0252473, entitled “Apparatus and Method for SterilizingMedical Devices,” published Sep. 7, 2017, the disclosure of which isincorporated by reference herein; and/or U.S. Pub. No. 2017/0252474,entitled “Method of Sterilizing Medical Devices, Analyzing BiologicalIndicators, and Linking Medical Device Sterilization,” published Sep. 7,2017, the disclosure of which is incorporated by reference herein.

In some cases, a biological indicator may be included in sterilizingcabinet (100, 150) along with the medical device during thesterilization process. The biological indicator may be activated beforeplacement to cause a microorganism contained therein to multiply unlessit is successfully sterilized during the procedure. After thesterilization process, the number of microorganisms present in thebiological indicator may be determined by the biological indicatoranalyzer (102) to ensure that the sterilization process was successfulfor the biological indicator, which will also indicate that thesterilization procedure was successful for the medical device.Biological indicator analyzer (102) may receive a biological indicatorand measure one or more characteristics of the biological indicator togather data that may be used to determine whether the biologicalindicator tests positive, indicating that contamination is present aftera sterilization procedure; or negative, indicating that no contaminationis present after the sterilization procedure.

By way of example only, the biological indicator and biologicalindicator analyzer (102) may be configured and operable in accordancewith at least some of the teachings of U.S. Pub. No. 2017/0253845,entitled “Self-Contained Biological Indicator,” published Sep. 7, 2017,the disclosure of which is incorporated by reference herein; U.S. Pub.No. 2017/0253905, entitled “Apparatus and Method for AnalyzingBiological Indicators,” published Sep. 7, 2017, the disclosure of whichis incorporated by reference herein; U.S. Pub. No. 2017/0252474,entitled “Method of Sterilizing Medical Devices, Analyzing BiologicalIndicators, and Linking Medical Device Sterilization,” published Sep. 7,2017, the disclosure of which is incorporated by reference herein;and/or U.S. Pub. No. 2018/0071421, entitled “Biological Indicator withVariable Resistance,” published Mar. 15, 2018, the disclosure of whichis incorporated by reference herein.

Server (106) may comprise a hospital record server or hospital localarea network server. Server (106) may receive information fromsterilizing cabinet (100) relating to sterilization procedures performedby the sterilizing cabinet (100), such as sterilization proceduredurations and results; whether a particular sterilization procedureprovided a subsequent indication of biological contamination; theidentification of a user or technician who initiated, canceled, orcomplete a sterilization procedure; consumable materials or suppliesused during a sterilization procedure; diagnostic information andsystems errors; and/or other information. Server (106) may also receivedata from biological indicator analyzer (102) via communication hub(20).

User device (108) may comprise a device such as a laptop computer, adesktop computer, a mobile device such as a smartphone, tablet, or othermobile computing device; or a proprietary device having similarcapabilities, such capabilities including wired or wirelesscommunication with devices such as communication hub (20), a processorand memory, a display, a user interface, and other capabilities. Userdevice (108) may be used to access and view information associated withone or more components (100, 102, 110, 106) of system (10) viacommunication hub (20); and may also be used to create or modifyconfigurations and settings of communication hub (20) and connecteddevices. A user of user device (108) may view information and configuredevices via, for example, a desktop software application, a mobiledevice software application, a web browser, or another softwareinterface that may allow user device (108) to exchange information withcommunication hub (20). While only one user device (108) is shown inFIG. 1 as being in communication with communication hub (20), severaluser devices (108) may be in communication with communication hub (20).Similarly, several sterilizing cabinets (100), several biologicalindicator analyzers (102), several servers (106), and several sterilityguide databases (110) may be in communication with communication hub(20).

Components (100, 102, 110, 106) of system (10) may each be coupled withcommunication hub (20) via any suitable wired and/or wirelesscommunication technology, such as Ethernet, Wi-Fi, Bluetooth, USB,infrared, NFC, and/or other technologies. Communication hub (20) mayrelay data, etc., between components (100, 102, 110, 106) of system (10)as described herein, such that communication hub (20) serves as anintermediary. Various suitable components and configurations that may beused to form communication hub (20) will be apparent to those skilled inthe art in view of the teachings herein. By way of example only,communication hub (20) and/or user device (108) may be configured andoperable in accordance with at least some of the teachings of U.S. Pub.No. 2017/0252472, entitled “Apparatus and Method to Link Medical DeviceSterilization Equipment,” published Sep. 7, 2017, the disclosure ofwhich is incorporated by reference herein; and/or U.S. Pub. No.2017/0252474, entitled “Method of Sterilizing Medical Devices, AnalyzingBiological Indicators, and Linking Medical Device Sterilization,”published Sep. 7, 2017, the disclosure of which is incorporated byreference herein

II. Overview of Exemplary Sterilization Process

FIG. 3 depicts an exemplary set of steps that system (10) could performto sterilize a medical device. Initially, sterilizing cabinet (100) maydisplay one or more sterilization cycles via touch screen display (160)and then receive a sterilization cycle selection (block 200) from theuser. Sterilizing cabinet (100) may also display instructions indicatingwhether a biological indicator should be used with the selectedsterilization cycle; and receive a biological indicator identification(block 202). A biological indicator may be placed inside sterilizationchamber (152) before the sterilization cycle begins and may remain insterilization chamber (152) during a sterilization cycle. The user maythus identify the particular biological indicator (block 202) before thebiological indicator is placed the sterilization chamber (152).

Selection of a sterilization cycle (block 200) and identification of abiological indicator (block 202) may define one or more requirements forthe configuration and arrangement of medical devices within sterilizingcabinet (100). A door of sterilization chamber (152) may be opened andinstructions may be displayed to guide a user through preparation of thesterilization cycle (block 204), including placement of the biologicalindicator, placement of medical devices, closing the door ofsterilization chamber (152), and/or other changes in preparation. Beforeinitiating the actual sterilization cycle (block 208), sterilizationcabinet (100) may also perform load conditioning (block 206) of themedical devices that are loaded in sterilization chamber (152). Suchload conditioning (block 206) may include verifying that sterilizationchamber (152) is sealed; verifying contents of sterilization chamber(152); checking physical characteristics of the contents ofsterilization chamber (152) such as moisture levels, content volume,content weight, internal temperature, or other characteristics; and/orperforming one or more conditioning steps that may include heattreatment, chemical treatment, plasma treatment, or other types oftreatment to reduce moisture, raise temperature, and/or otherwiseprepare the medical devices in sterilization chamber (152) for thesterilization cycle.

Once the load conditioning (block 206) has been completed, the selectedsterilization cycle itself may be performed (block 208). Thesterilization cycle (block 208) may include exposing the medicaldevice(s) in sterilizing chamber (152) to pressurized sterilant gas,further heat treatment, chemical treatment, plasma treatment, vacuumtreatment, and/or other types of sterilization procedures. After thesterilization cycle (block 208) is completed, the complete sterilizationresults may be displayed to a user via touch screen display (160);transmitted to server (106); printed locally; and/or displayed,transmitted, and/or stored via other devices as may be desirable.

Sterilization cabinet (100) may also provide results (block 210) of thesterilization cycle. This provision of results (block 210) may includeresults from analysis of a biological indicator via biological indicatoranalyzer (102). These results may include a positive or negativeindication of contamination present in the biological indicator at thecompletion of the sterilization cycle (block 208). In cases where thebiological indicator suggests that contamination is present aftercompletion of the sterilization cycle (block 208), additional actionsmay be taken such as alerting a user of the positive test and analysisof sterilization cycle history to determine if other past cycles may bethe cause of the contamination; and/or if subsequently sterilizedmedical devices may need to be re-sterilized.

III. Exemplary Method for Identifying a Medical Instrument

Sterility guide database (110) comprises a set of records that associatea plurality of medical devices with a plurality of sterilization devices(e.g., sterilizing cabinet (100), etc.), sterilization procedures,sterilization cycles, and sterilization materials (e.g., biologicalindicators, detergents, sterilant, etc.); and indicate for each medicaldevice association whether the particular sterilization device,procedure, or material has been verified as compatible or usable tosterilize that particular medical device. Sterility guide database (110)may comprise a database, table, file, or other data storage type storedon a computer (e.g., a cloud computer or cloud storage, server (106), oranother physical server) and accessible to communication hub (20). Otherlocations and forms that sterility guide database (110) may take will beapparent to those skilled in the art in view of the teachings herein.

The exemplary methods described below may be implemented on a systemsuch as system (10) to further mitigate the risk of human errors orequipment errors resulting in failed sterilization of medical devices,damage to medical devices, or waste of sterilization materials andresources. Several of the disclosed methods may benefit fromidentification of medical devices when the sterilization process isfirst configured to, for example, automatically select appropriatehardware and process configurations, verify compatibility, and takeother similar steps based upon such an identification. Where thedescription or claims indicate that a step, determination,identification, or other decision or conclusion is performed “based on”or “based upon” certain input, data, or other factors, other factors orinputs may also influence the outcome. Accordingly, such descriptionsshould be interpreted to cover situations where the outcome is basedonly on or upon the described factors, as well as situations where theoutcome is based at least on or upon the described factors in additionto others that are not explicitly described or listed.

While manual identification of medical devices by users of system (10)may be accurate in some cases, automatic identification may furthermitigate the risk of human error or equipment error resulting inmisidentification of a medical device. The identity of a medical devicemay vary by implementation but could include one or more of a devicetype (e.g., an endoscope, a cutting instrument, a suction instrument,etc.), a device manufacturer, a semi-unique device model number, aunique device serial number, or other information. FIG. 4 shows anexemplary set of steps (300) that may be performed by or with system(10) to automatically determine the identity of a medical device. When amedical device is received (block 302) by a user of a device of system(10), such as sterilizing cabinet (100) or user device (108), variousoptions may be available for identifying the medical device using thefeatures and capabilities of system (10).

As an example, a user of sterilizing cabinet (100) may identify (block303) the medical device based upon an image capture of the medicaldevice, portions of the medical device, or identifying symbols, images,or text of the medical device. Image capture may be performed byinteracting with features that are available to the device in use, suchas reader (166) of sterilizing cabinet (100) or an alternate input ofuser device (108). This could include, for example, an image capturedevice capturing image data of a profile of the entire medical deviceand identifying it using an image analysis process; capturing image dataof an end effector or other portion of the medical device andidentifying it using an image analysis process; capturing image data ofa serial number or model number present on the medical device, parsingthe serial number or model number into text, and then identifying themedical device directly or using a device lookup table that is locallystored, or stored on server (106), stored in sterility guide database(110), or stored on another device or server; capturing image data of abarcode, QR code, or other visual identifier that encodes or otherwiserepresents data, and using that data to identify the medical deviceusing the device lookup table; and other similar processes.

By way of further example only, sterilizing cabinet (100) mayautomatically identify (block 303) the medical device using advancedoptical analysis, including but not limited to Fourier TransformInfrared Spectroscopy. As yet another merely illustrative example,sterilizing cabinet (100) may automatically identify (block 303) themedical device using mechanical sensing, including but not limited toweight plus dynamic dosing or loading response characteristics (e.g.,pressure/peroxide concentration profiles). Various suitable hardwarecomponents and algorithms that may be used to provide automatedidentification (block 303) of the medical device by sterilizing cabinet(100) will be apparent to those skilled in the art in view of theteachings herein.

A successful identification (block 303) of the medical device based onimage capture may be used, by itself or in combination with the resultsof other attempts at identification, to propose (block 312) a medicaldevice identity to a user and receive confirmation from the user thatthe medical device was correctly identified, as will be described inmore detail below.

As another example, a user of sterilizing cabinet (100) may identify(block 304) the medical device based upon device tracking recordsassociated with the medical device and stored on server (106) or anotherdevice of system (10). A medical device or other material may be trackedthroughout its lifetime to provide tracking information that may be usedto locate lost or misplaced medical devices, determine current medicaldevice inventory, audit processes related to handling medical devicesbefore and after procedures, and other similar uses. Such trackinginformation may be generated by performing steps (314) such as thoseshown in FIG. 5. Whenever a medical device arrives (block 316) ordeparts (block 318) from a touch-point with a user having a devicecapable of interacting with system (10), such as sterilizing cabinet(100) or user device (108), the medical device may be identified (block320) manually or automatically using some or all of the steps of FIG. 5,or another identification process. Once identified (block 320), system(10) may identify (block 322) a set of tracking records or create a newset of tracking records associated with the medical device that arestored in server (106), sterility guide database (110), or anotherserver or location, and update (block 324) that set of tracking recordsto reflect the present arrival (block 316) or departure (block 318) ofthe medical device from the current touchpoint.

Information added to tracking records when they are updated (block 324)may include, when a device is arriving (block 316), the location thedevice arrived at, the location the device originated from, the time ofarrival, a user that received the device upon arrival, the condition ofthe device upon arrival (e.g., new, used, sterile, non-sterile), anyprocesses or procedures to be performed on or with the device while atthe current location, a future destination of the device, and othersimilar information. When a device is departing (block 318), updated(block 324) information may include the location the device is departingfrom, the location the device is departing to, the time of departure, auser that received the device when it departed, the condition of thedevice upon departure (e.g., new, used, sterile, non-sterile), anyprocesses or procedures performed on the device at the location it isdeparting from, and other similar information.

Returning to FIG. 4, such tracking information may be used to determinethe identity (block 304) of a device that is arriving at a location suchas sterilizing cabinet (100) or user device (108). For example, trackinginformation associated with Medical Device X may indicate that thedevice departed Procedure Room A at 1:00 PM and is being routed toSterilizing Cabinet B by Technician C. Technician D, located atSterilizing Cabinet B, may receive an unidentified medical device at1:15 PM from Technician C. Technician D, using Sterilizing Cabinet B,may access tracking information and identify (block 304) the medicaldevice as Medical Device X based upon the fact that it arrived withTechnician C, at its intended location Sterilizing Cabinet B, within areasonable time frame (e.g., 15 minutes) of its departure from ProcedureRoom A. Other data that may be stored and created as part of thetracking information, and other methods for using such data to identify(block 304) a medical device will be apparent to one skilled in the artin view of the teachings herein.

As another example, as has already been described in some detail inrelation to identifying (block 303) a medical device based on imagecapture, a user of sterilizing cabinet (100) may identify (block 306)the medical device based upon an optical identifier. Where sterilizingcabinet (100) or user device (108) is capable of capturing andinterpreting optical identifiers (e.g., with reader (166) or analternate input of user device (108)), a unique or semi-unique opticalidentifier may be placed on the medical device that may be captured andchecked against a record lookup table on server (106) or sterility guidedatabase (110) to identify the device. This could include using anoptical scanner to capture a barcode, QR code, or other visual markingintended to be captured by the optical scanner and configured to encodeor otherwise indicate data that may be used to identify the devicedirectly or using the record lookup table.

As another example, a user of sterilizing cabinet (100) may identify(block 308) the medical device based upon a wireless identifier. Wheresterilizing cabinet (100) or user device (108) is capable of capturingand interpreting wireless identifiers (e.g., with reader (166) oralternate input (194)), a unique or semi-unique wireless identifier maybe placed on the medical device that may be captured and checked againstthe record lookup table to identify the device. This could include usingan RFID transceiver and RFID chip, a Bluetooth Transceiver and beacon,an NFC transceiver and beacon, a Wi-Fi transceiver and Wi-Fi antenna, orother wireless communication device combinations to wirelesslycommunicate data between the sterilizing cabinet (100) and the chip,beacon, or other device placed on or within, or transported with themedical device. Data provided from the medical device to the sterilizingcabinet (100) may then be used to identify the medical device directlyor using the record lookup table.

As another example, a user of sterilizing cabinet (100) may identify(block 310) the medical device based upon a serial number or othernumeric identifier input. A numeric identifier may be input for amedical device by, for example, hand-keying with a keyboard or touchscreen display (160), or by connecting a power or data port of themedical device to the sterilizing cabinet (100) in order toautomatically retrieve the numeric identifier from a chip or memory ofthe medical device. As with prior examples, the numeric identifier maybe used to identify the medical device directly or using the recordlookup table.

As has been mentioned, after one or more medical device identificationsare made, the sterilizing cabinet (100), user device (108), or otherdevice performing the identifications may propose (block 312) anidentity for the medical device to a user via a display or other userinterface; and receive confirmation from the user of the device identityvia a keyboard, mouse, touch screen display (160), or other userinterface available to that device. Where only a single identificationmethod is used, or multiple identification methods are used anddetermine a common identity, only one option may be proposed (block 312)to a user.

Where multiple identification methods are used, and multiple identitiesare determined, each option may be proposed (block 312) to a user; or amost likely identity may be determined and proposed (block 312) to theuser, with other identities being discarded or only proposed (block 312)if the user does not confirm the first identity. In someimplementations, identities may be proposed (block 312) and displayedwith additional information such as a confidence level (e.g., high orlow, percentage based), a source of the identification (e.g., identifiedby tracking records and optical identifier), or other information thatis available to system (10) and that may aid user in confirming themedical device identity. Confidence levels and other determinationsrelating to the accuracy of a determined identity may be configured byan administrator of the system and based upon the source of theidentification (e.g., manually input serial number may be a lowerconfidence while automatically scanned optical identifier may be ahigher confidence), and adjusted over time based upon real world use ofthe system (e.g., raising the level of confidence in manually inputserial numbers after they are determined to be highly accurate).

IV. Exemplary Method for Verifying Medical Instrument SterilizationCompatibility

Different medical devices may have different requirements forsterilization, and so sterilizing cabinet (100) is configurable toperform sterilization procedures having different characteristics. Thecharacteristics of a sterilization procedure may be manually configuredor may be selected based upon a selected sterilization cycle (block200). These characteristics may include such factors as preciseplacement of a medical device within the sterilizing cabinet (100)(e.g., top shelf, bottom shelf, middle of shelf), number of medicaldevices that may be placed within the sterilizing cabinet (100) at onetime, particular sterilant to use during a procedure, the total time ofthe procedure, a number of different stages of a procedure and a timefor each stage, an appropriate biological indicator to use andbiological indicator placement, and other similar characteristics. Asterilization cycle may combine one or more of these characteristics orothers into a pre-configured process that may be selected to beperformed by the sterilizing cabinet (100) based upon a single userselection.

Whether a sterilization process is manually configured or configured bythe selection (block 200) of a sterilization cycle to be performed,there is a possibility for user error resulting in an unsterilizedmedical device returning to service, or a sterilized medical devicebeing unnecessarily re-sterilized, if a user misunderstands theselection process or misidentifies the medical device and performs asterilization procedure that is not adequate to completely sterilize themedical device. Even where there is no true user error (e.g., the usermakes appropriate selections based upon their training and the medicaldevice involved), some medical devices may not be verifiably compatiblewith certain sterilization cycles or sterilizing cabinets (100), eventhough users and providers believe they are.

For example, an older version of a medical device may have been testedand verified as compatible with one or more sterilization cycles ofsterilizing cabinet (100). A newer version of the medical device may bereleased that is seemingly identical to the older version, but due tochanges on the interior of the device that are imperceptible to the enduser, the newer version of the medical device may be incompatible withone or more cycles of sterilizing cabinet (100).

To address such concerns, the sterility guide database (110) stores anumber of records associating medical devices with sterilizationequipment and processes, such as the sterilization cycles of sterilizingcabinet (100); and provides an indication of compatibility. Thesterility guide database (110) may be populated with data by a singleparty responsible for maintaining it (e.g., a manufacturer ofsterilizing cabinets or a medical safety association); or may bepopulated by multiple users of the sterility guide database (e.g.,medical device manufacturers). Data may be created and populated basedupon targeted testing of new medical devices, such as focused testing onnew devices as they are released to determine whether they aresuccessfully sterilized by a device or procedure; or may be created andpopulated based upon similarities to prior devices, simulation models,or other techniques. In effect, the sterility guide database (110) maybe accessed by a user to provide an assurance that a particular medicaldevice is sterile after a procedure.

FIG. 6 shows a set of exemplary steps (400) that may be performed withsystem (10) to verify the compatibility of a sterilization procedurewith a particular medical device using the sterility guide database(110). When a non-sterile medical device is received, a user may begin(block 402) configuring a sterilization cycle for that medical deviceusing the sterilizing cabinet (100). While the steps of FIG. 6 may beperformed at the beginning (block 402) of configuration of asterilization cycle, they may alternatively or additionally be performedafter the performance of a sterilization cycle as may be desired in someimplementations. If the medical device is identifiable (block 404),using steps such as those shown in FIG. 5, the sterilizing cabinet (100)may receive (block 412) the device identification automatically. If thedevice is not identifiable (block 404), the sterilizing cabinet (100)may provide (block 406) a device input interface to a user and receive(block 408) a manual identification of the medical device from the user.

The device input interface may include, for example, a set of selectionmenus, drop down menus, buttons, boxes, or other interface elements thatallow a user to browse through a list of medical devices to identify themedical device. This could include, for example, allowing a user toselect a manufacturer from a menu and providing a list of device typesprovided by that manufacturer, allowing a user to select a device typeand providing a list of device models included in that device type, andallowing a user to select a device model. This could also includeproviding a user with a series of questions about the form (e.g., “Whatis the total length of the device?”), features (e.g., “Does the devicehave a battery?”), or other aspects of the medical device that arestructured to narrow down and identify the device. The interface may beprovided through touch screen display (160) or otherwise.

Once the medical device is identified, whether automatically (block 412)or manually (block 408), the sterilizing cabinet (100) may access thesterility guide database (100) and receive (block 410) a set ofassurance data associated with the medical device. The set of assurancedata may indicate one or more sterilization cycles, sterilizing cabinetssuch as sterilizing cabinet (100), sterilants, or other devices orprocesses that have been verified as being compatible with the medicaldevice. Sterilizing cabinet (100) may then verify (block 414) thecompatibility of its available sterilization cycles or other features;and, where the user performs a verified compatible sterilization cycle,update (block 416) the sterilization cycle results for thatsterilization cycle. Sterilization cycle results are a set of recordsstored on server (106) or another device of system (10) that indicate,for each sterilization cycle performed on that device, thecharacteristics of the cycle, the medical devices included in the cycle,and the results of the cycle as indicated by a biological indicator usedwith the cycle. The updated (block 416) cycle results may additionallyinclude information from the sterility guide database (110) indicatingthat the performed cycle has been assured as being compatible with themedical device, which provides further assurance that the medical issterile after the cycle.

Where a user selects a sterilization cycle or process that cannot beverified (block 414) as being compatible with the medical device,sterilizing cabinet (100) may present the user with a warning ornotification of the lack of assurance; and ask the user to override(block 418) the warning to continue performing the possibly incompatiblesterilization cycle. Where the user overrides (block 418) thenotification and performs the possibly incompatible sterilization cycle,the sterilizing cabinet (100) may provide (block 420) an overridenotification and update the sterilization cycle results. The overridenotification may be configured to be provided to the user performing theoverride, to users responsible for the sterilizing cabinet (100) itselfor the section of the hospital where it is present, to users responsiblefor sterilization procedures for the hospital generally, or other usersas may be desired and configured by an administrator of system (10).Sterilization cycle results may be updated to reflect that, while abiological indicator used with the sterilization cycle may haveindicated that it was successful, system (10) was unable to provide anassurance that the medical device was compatible with the performedcycle and successfully sterilized, based upon the information availablevia sterility guide database (110).

Where the user does not override (block 418) the notification ofpossible incompatibility, the sterilizing cabinet (100) may display(block 422) one or more options for sterilizing the medical device forwhich assurance of compatibility is available. This could include, forexample, selecting a different sterilization cycle on sterilizingcabinet (100), or transporting the medical device to another type ofsterilizing cabinet or device.

FIGS. 7-13 show screenshots of exemplary interfaces that may bedisplayed to a user via touch screen display (160) of sterilizingcabinet (100), or via another display or device, during one or more ofthe steps of FIG. 6, including during configuration of a sterilizationcycle to be performed with a medical device.

FIG. 7 shows an interface (500) that displays a set of cycle information(502) associated with a sterilization cycle that is configured and readyto be performed, or that has been performed on sterilizing cabinet(100). Set of cycle information (502) comprises a load description (504)indicating one or more medical devices that are part of the load of thesterilization cycle. An assurance window (506) may be displayed by, forexample, hovering over or clicking on a medical device shown in loaddescription (504). Assurance window (506) comprises a list ofsterilizing cabinets or devices and provides an assurance indication(508) for one or more sterilization cycles available to thosesterilizing cabinets, based upon assurance data received (block 410) forthe medical device. Assurance window (506) may also provide a lack ofassurance indication (510) for one or more sterilizing cabinets (100)for which the assurance data received (block 410) does not provideassurance of compatibility. Lack assurance indication (510) may compriseinstructions for seeking or requesting assurance; or may include aclickable button or other interactive feature that may automaticallyrequest assurance from a party responsible for maintaining the sterilityguide database (100).

FIG. 8 shows an interface (512) that displays a more detailed view ofone or more medical devices present in a sterilization cycle load (514).Interface (512) shows a set of rows showing additional information on afirst medical device (516) and a second medical device (518) such asdevice manufacturer, device name, and model number, and a set of columnsproviding an assurance indication (520) for one or more sterilizationcycles available to those medical devices. Interface (512) may alsoprovide a lack of assurance indication where appropriate.

FIG. 9 shows an interface (522) that displays a view of informationassociated with sterilization cycles (526) performed with asterilization device (524). Interface (524) also shows a device cyclesummary (528) comprising a set of aggregate information based uponinformation associated with sterilization cycles (526), and an assurancerate (530) indicating an aggregate percentage of cycles that wereverified (block 414) as compatible rather than being overridden (block418) and performed.

FIG. 10 shows an interface (532) that displays various notificationoptions for different types of alerts (536) that may be provided bysystem (10) and different forms of communication (534) that may be usedby system (10) to provide the types of alerts (536) to one or more usersof system (10). An administrator of system (10) may use interface (532)to configure various alert scenarios, including configuring system (10)to provide alerts to one or more users or types of users based upon anindication of an unverified sterilization cycle being performed (538).Such an alert may be generated and communicated to users based upon theconfigured forms of communication (534) when a user overrides (block418) a notification that a sterilization cycle cannot be assured asbeing compatible with a medical device, as part of providing (block 420)override notification.

FIG. 11 shows an interface (540) that displays a set of sterilizationdevices available to a user (e.g., a device the user is presentlyinteracting with, devices available in the same room, devices availablein other areas of a hospital) and whether they have been assured asbeing compatible with the medical device for which the sterilizationcycle will be performed. As can be seen, a first sterilizing cabinet(542) and a second sterilizing cabinet (544) appear in a manner thatindicates they have compatible sterilization cycles that may be usedwith the medical device based upon an assurance of compatibilityreceived (block 410) from the sterility guide database (110).Conversely, a third sterilizing cabinet (546) and a sterilizing device(548) appear in a manner that indicates they have not been assured ascompatible with the medical device, based upon the received (block 410)assurance data lacking any indication of compatibility with the medicaldevice. A user selection of the third sterilizing cabinet (546) mayresult in interface (540) presenting a warning indicating that the usermust override (block 418) the unassured sterilization cycle to continue.

FIG. 12 shows an interface (550) displaying a hospital levelinstrumentation status (552) showing information on a plurality ofmedical devices currently in use at a particular hospital, building, orsite, and their assurance level for sterilizing cabinets andsterilization cycles available at that same locale. A set of medicaldevices are displayed in rows, including a first medical device (554)and a second medical device (556), and a first column presentsinformation associated with those devices such as device manufacturer,device name, model number, and manufacturer's notes related to thedevice. A set of columns (560) show for each sterilizing cabinet a setof sterilization cycles that are compatible with each of the firstmedical device (554) and the second medical device (556). Interface(550) may be used by an administrator or person responsible for medicaldevice sterilization to easily view each medical device currently in useat the hospital, and the compatibility assured sterilization resourcesavailable for each medical device, to verify that all presently usedmedical devices have some level of compatibility assured sterilizationavailable.

FIG. 13 shows an interface (562) displaying an alternate view of some ofthe data shown in FIG. 12. The alternate view of interface (562)displays information on a set of medical devices (564) currently in useat a particular hospital, site, or other location, as well as thecompatibility assurances for each medical device as discussed in thecontext of FIG. 12; and additionally shows a hospital assurance rate(566). Hospital assurance rate (566) may indicate a percentage of theset of medical devices (564) that have some assured compatibility withsterilizing devices present at the hospital; or may indicate anaggregate percentage of compatibility assured sterilization cyclesperformed at the hospital during a period of time. Additional interfacesand variations on the described interfaces exist and will be apparent toone skilled in the art in view of the teachings herein.

V. Exemplary Method for Automatic Sterilization Cycle Selection

While the disclosed systems and methods mitigate risks associatedsterilization procedures and provide assurances of successfulsterilization, the below described method may be implemented in system(10) individually or in combination with these other techniques tofurther reduce the chance of error. FIG. 15 shows an exemplary set ofsteps (600) that may be performed by or with system (10) toautomatically configure a sterilizing cabinet such as sterilizingcabinet (100).

When a user receives a medical device at sterilizing cabinet (100) andbegins (block 602) the sterilization cycle configuration, the medicaldevice may be identified (block 604) by performing steps such as thoseshown in FIG. 5. If the medical device is successfully identified (block604) and confirmed, the sterilizing cabinet (100) may automaticallyreceive the medical device identity. If the device is not identifiable(block 604), the sterilizing cabinet (100) may provide (block 606) adevice input interface to a user; and receive (block 608) a manualidentification of the medical device from the user.

The device input interface may include, for example, a set of selectionmenus, drop down menus, buttons, boxes, or other interface elements thatallow a user to browse through a list of medical devices in order toidentify the medical device. This could include, for example, allowing auser to select a manufacturer from a menu and providing a list of devicetypes provided by that manufacturer, allowing a user to select a devicetype and providing a list of device models included in that device type,and allowing a user to select a device model. This could also includeproviding a user with a series of questions about the form (e.g., “Whatis the total length of the device?”), features (e.g., “Does the devicehave a battery?”), or other aspects of the medical device that arestructured to narrow down and identify the device. The interface may beprovided through touch screen display (160) or otherwise.

Once the medical device is identified, whether automatically (block 612)or manually (block 608), the sterilizing cabinet (100) may select acompatible sterilization cycle based upon the medical device identity.This could include, for example, accessing server (106) to identifycompatible sterilization cycles associated with the medical device,accessing the sterility guide database (110) to identify compatibilityassured sterilization cycles associated with the medical device, orboth. In some cases, the sterilizing cabinet (100) may also select(block 610) an associated cycle based entirely upon or in part upontracking information provided with the medical device upon arrival, ashas been described.

In some scenarios, the identified medical device may not be found in thesterility guide database (110), yet the user reasonably believes thatthe medical device is in fact compatible with sterilizing cabinet (100)(e.g., due to a notice published by the manufacturer of the medicaldevice or a notice published by the manufacturer of sterilizing cabinet(100), etc.). In some such scenarios, sterilizing cabinet (100) maypresent the user with a user interface that enables the user to updatethe sterility guide database (110) to include that medical device. Thus,the next time a user tries to sterilize the same medical device insterilizing cabinet (100), a check of sterility guide database (110)will confirm that the medical device is compatible with sterilizingcabinet (100). As another variation of this concept, sterilizing cabinet(100) may present the user with a user interface that enables the userto compile separate listings of medical devices that are compatible withsterilizing cabinet (100). Such separate listings may be storedelsewhere (i.e., not in sterility guide database (110)): or may bestored in sterility guide database (110) (e.g., in a listing that isseparate from manufacturer-defined listing(s)). In some such versions,sterilizing cabinet (100) may first check the manufacturer-definedlisting(s) in sterility guide database (110); and if the medical deviceis not found in the manufacturer-defined listing(s), then check theuser-defined listing(s).

Regardless of whether the medical device identification is performedmanually (block 608) or automatically (block 612), the selected (block610) sterilization cycle may be presented to a user via the sterilizingcabinet (100) for confirmation (block 614), and, where a user confirmsthat the selected (block 610) cycle should be performed, the cycle maybe automatically performed (block 616). Where the user does not wish toproceed with the selected (block 610) cycle and does not confirm (block614) the sterilization cycle, the sterilizing cabinet (100) may receive(block 618) a configuration override that causes a differentsterilization cycle to be selected; or that modifies one or morecharacteristics of the selected sterilization cycle. The sterilizingcabinet (100) may provide (block 620) an override notification, similarto prior discussion of providing (block 420) override notifications; andmay perform (block 616) the override sterilization cycle.

System (10) and sterilizing cabinet (100) may be configured to performsteps such as those shown in FIG. 6, or steps such as those shown inFIG. 15, or both, as may be desirable. In implementations performingsteps such as those shown in both FIG. 6 and FIG. 15, such steps may beperformed in series or in parallel as may be desirable. For example,where the sterilization cycle is selected (610) based upon data from thesterility guide database (110), the configured cycle may be inherentlyassociated with an assurance of compatibility with the medical devicefrom the sterility guide database (110). Such an assurance could bepresented in addition to other information when a user is prompted toconfirm (block 614) the selected (block 610) cycle, and cycle resultsmay be updated (block 416) with the assurance after the cycle isperformed (block 616) and the cycle results are generated.

VI. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A device usable with a sterilization system for a medical device, thedevice comprising: (a) a processor and a memory; (b) a communicationdevice; (c) a user input; and (d) a display; wherein the processor isconfigured to: (i) receive a device indicator associated with themedical device, (ii) access a set of medical device records anddetermine an identity of the medical device based upon an association ofthe device indicator with the set of medical device records. (iii)configure at least one risk mitigation process based upon the identityof the medical device, and (iv) configure a sterilization cycle to beperformed on the medical device based upon the at least one riskmitigation process.

Example 2

The device of Example 1, wherein the device is a sterilizing cabinet;wherein the communication device is a wireless transceiver configured tobe connected to the sterilization system via a wireless communicationnetwork, wherein the user input comprises a touchscreen and an opticalreader; wherein the identifier is a model number associated with aunique description of the medical device; wherein the identity is theunique description of the medical device.

Example 3

The device of any one or more of Examples 1 through 2, wherein thedevice indicator is a set of device tracking information received fromthe sterilization system; wherein the set of device tracking informationindicates an in-transit medical device leaving from an origin and havinga destination of the device; wherein the set of medical device recordsassociate the in-transit medical device with the identity of the medicaldevice; wherein the processor is further configured to determine thatthe medical device is the in-transit medical device.

Example 4

The device of any one or more of Examples 1 through 3, wherein the userinput comprises an optical reader that is operable to read data encodedin an optical identifier; wherein the optical reader is configured toreceive the device indicator after the optical reader reads the opticalidentifier; wherein the set of medical device records associate theoptical identifier with the identity of the medical device.

Example 5

The device of any one or more of Examples 1 through 4, wherein the userinput comprises a text input that is operable to provide a textidentifier to the device; wherein the text input is configured toreceive the device indicator as the text identifier; wherein the set ofmedical device records associate the text identifier with the identityof the medical device.

Example 6

The device of any one or more of Examples 1 through 5, wherein theprocessor is further configured to: (i) after the identity of themedical device is determined, display the identity to a user via thedisplay, (ii) receive an identity response from a user via the userinterface, (iii) where the identity response indicates that the identityis not correct, provide a manual device input interface via the display,wherein the manual device input interface comprises a set of prompts foradditional information operable by the user to determine a new identityof the medical device, and (iv) configure the at least one riskmitigation process based upon the new identity instead of the identity.

Example 7

The device of any one or more of Examples 1 through 6, wherein the atleast one risk mitigation process comprises a compatibility assuranceprocess, wherein the compatibility assurance process is configured tocause the processor to: (i) determine a sterilizing cabinet identifierassociated with the sterilization cycle, (ii) determine a sterilizationcycle type associated with the sterilization cycle, and (iii) receive adevice assurance indicator from a sterility guide database of thesterilization system based upon the sterilizing cabinet identifier, thesterilization cycle type, and the identity of the medical device,wherein the device assurance indicator indicates whether the medicaldevice is compatible with a sterilizing cabinet associated with thesterilizing cabinet identifier and a sterilization cycle associated withthe sterilization cycle type.

Example 8

The device of Example 7, wherein the processor is further configured to:(i) determine a set of sterilizing cabinets that are present in thesterilization system, (ii) determine, for each sterilizing cabinet inthe set of sterilizing cabinets, a set of sterilization cycles that eachsterilizing cabinet is capable of performing, (iii) receive a set ofdevice assurance indicators for each sterilizing cabinet of the set ofsterilizing cabinets from the sterility guide database and determine aset of compatible sterilization cycle options based upon the set ofdevice assurance indicators, (iv) display the set of compatiblesterilization cycle options via the display, (v) receive a selection viathe user input, wherein the selection is associated with an option ofthe set of compatible sterilization cycle options, and (vi) configurethe sterilization cycle based upon the selection.

Example 9

The device of any one or more of Examples 7 through 8, wherein theprocessor is further configured to, when the device assurance indicatorindicates that the medical device is compatible: (i) indicate via thedisplay that the sterilization cycle is compatible with the medicaldevice, and (ii) upon completion of the sterilization cycle, add acompatibility assured indicator to a cycle result dataset, wherein thecycle result dataset describes the performance of the sterilizationcycle and the compatibility assured indicator indicates that the medicaldevice was compatible with the sterilization cycle.

Example 10

The device of Example 9, wherein the processor is further configured to,when the device assurance indicator indicates that the medical device isnot assured as compatible: (i) display via the display a compatibilitywarning that indicates the sterilization cycle is not assured ascompatible with the medical device, (ii) receive a confirmation via theuser input to override the compatibility warning and proceed with thesterilization cycle, (iii) provide an unverified cycle alert via thecommunication device as an electronic message to one or more recipients,and (iv) upon completion of the sterilization cycle, add an assurancewarning indicator to a cycle result dataset, wherein the cycle resultdataset describes the performance of the sterilization cycle and thecompatibility assured indicator indicates that the medical device wasnot assured as compatible with the sterilization cycle.

Example 11

The device of any one or more of Examples 7 through 10, wherein theprocessor is further configured to cause a device cycle summaryinterface to display via the display, wherein the device cycle summaryinterface comprises: (A) a sterilizing cabinet descriptor, (B) a list ofcycle results for sterilization cycles performed on a sterilizingcabinet associated with the sterilizing cabinet descriptor, and (C) anassurance rate indicating the portion of the list of cycle resultsassociated with a compatible device assurance indicator.

Example 12

The device of any one or more of Examples 7 through 11, wherein theprocessor is further configured to cause an instrumentation assurancesummary interface to display via the display, wherein theinstrumentation assurance summary interface comprises: (A) a set ofmedical device descriptors for each medical device in service at alocation, (B) a set of sterilizing equipment descriptors for sterilizingdevices in service at the location, (C) a set of assurance descriptorsindicating which of the sterilizing devices in service at the locationare assured as compatible for each medical device in service at thelocation, and (D) an assurance rate indicating whether any of themedical devices in service at the location are not compatible with anysterilizing devices in service at the location.

Example 13

The device of Example 12, wherein the instrumentation assurance summaryinterface further comprises a request assurance feature associated withan unverified medical device of the set of medical device descriptors;wherein the request assurance feature may be interacted with via theuser interface to cause an electronic communication to be sent to arecipient associated with the sterility guide database; wherein theelectronic communication describes the unverified medical device and theset of sterilizing equipment descriptors.

Example 14

The device of any one or more of Examples 1 through 13, wherein the atleast one risk mitigation process comprises an automatic cycleselection, wherein the compatibility assurance process is configured tocause the processor to: (i) determine an approved cycle configurationbased upon the identity of the medical device, and (ii) configure thesterilization cycle based upon the approved cycle configuration.

Example 15

The device of Example 14, wherein the approved cycle configuration isassociated with a device assurance indicator, wherein the deviceassurance indicator is configured to be received from a sterility guidedatabase based upon the identity of the medical device, wherein thedevice assurance indicator is further configured to indicate that themedical device is compatible with the sterilization cycle.

Example 16

A method for configuring a sterilization system to sterilize a medicaldevice comprising the steps: (a) receiving a device indicator that isassociated with the medical device; (b) accessing a set of medicaldevice records; (c) determining an identity of the medical device basedupon an associated of the device indicator with the set of medicaldevice records; (d) configuring at least one risk mitigation processbased upon the identity of the medical device; and (e) configuring asterilization cycle to be performed on the medical device based upon theat least one risk mitigation process.

Example 17

The method of Example 16, wherein configuring the at least one riskmitigation process comprises the steps: (i) determining a sterilizingcabinet identifier associated with the sterilization cycle, (ii)determining a sterilization cycle type associated with the sterilizationcycle, and (iii) receiving a device assurance indicator from a sterilityguide database of the sterilization system based upon the sterilizingcabinet identifier, the sterilization cycle type, and the identity ofthe medical device, and wherein the device assurance indicator indicateswhether the medical device is compatible with a sterilizing cabinetassociated with the sterilizing cabinet identifier and a sterilizationcycle associated with the sterilization cycle type.

Example 18

The method of Example 17, further comprising the steps: (a) determininga set of sterilizing cabinets that are present in the sterilizationsystem; (b) determining for each sterilizing cabinet in the set ofsterilizing cabinets, a set of sterilization cycles that eachsterilizing cabinet is capable of performing; (c) receiving set ofdevice assurance indicators for each sterilizing cabinet of the set ofsterilizing cabinets from the sterility guide database and determine aset of compatible sterilization cycle options based upon the set ofdevice assurance indicators; (d) displaying the set of compatiblesterilization cycle options to a user of the sterilization system; (e)receiving a selection from the user, wherein the selection is associatedwith an option of the set of compatible sterilization cycle options; and(f) configuring the sterilization cycle based upon the selection.

Example 19

The method of any one or more of Examples 16 through 18, whereinconfiguring the at least one risk mitigation process comprises thesteps: (i) accessing a database and retrieving a set of medical devicerecords, (ii) determining an approved cycle configuration based upon theidentity of the medical device and the set of medical device records,and (iii) configuring the sterilization cycle based upon the approvedcycle configuration.

Example 20

A sterilization system comprising: (a) a sterilizing cabinet operable toperform a sterilization cycle on a medical device; (c) a sterility guidedatabase comprising a set of assurance indicators, the set of assuranceindicators indicating a plurality of sterilizing cabinets that have beenassured as compatible with a plurality of medical devices; and (d) acommunication hub configured to provide communication between thesterilizing cabinet and the sterility guide database; wherein thesterilizing cabinet is configured to: (i) receive a device indicatorassociated with the medical device, (ii) access a set of medical devicerecords and determine an identity of the medical device based upon anassociation of the device indicator with the set of medical devicerecords, (iii) determine a sterilizing cabinet identifier associatedwith the sterilizing cabinet and a sterilization cycle type associatedwith the sterilization cycle, (iv) receive an assurance indicator fromthe sterility guide database based upon the sterilizing cabinetidentifier, the sterilization cycle type, and the identity of themedical device, (v) configure the sterilization cycle to be performed onthe medical device based upon the assurance indicator.

VII. Miscellaneous

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one skilled in the artwithout departing from the scope of the present invention. Several ofsuch potential modifications have been mentioned, and others will beapparent to those skilled in the art. For instance, the examples,embodiments, geometrics, materials, dimensions, ratios, steps, and thelike discussed above are illustrative and are not required. Accordingly,the scope of the present invention should be considered in terms of thefollowing claims and is understood not to be limited to the details ofstructure and operation shown and described in the specification anddrawings.

We claim:
 1. A device usable with a sterilization system for a medicaldevice, the device comprising: (a) a processor and a memory; (b) acommunication device; (c) a user input; and (d) a display; wherein theprocessor is configured to: (i) receive a device indicator associatedwith the medical device, (ii) access a set of medical device records anddetermine an identity of the medical device based upon an association ofthe device indicator with the set of medical device records, (iii)configure at least one risk mitigation process based upon the identityof the medical device, and (iv) configure a sterilization cycle to beperformed on the medical device based upon the at least one riskmitigation process; wherein the at least one risk mitigation processcomprises a compatibility assurance process, wherein the compatibilityassurance process is configured to cause the processor to: (A) determinea sterilizing cabinet identifier associated with the sterilizationcycle, (B) determine a sterilization cycle type associated with thesterilization cycle, and (C) receive a device assurance indicator from asterility guide database of the sterilization system based upon thesterilizing cabinet identifier, the sterilization cycle type, and theidentity of the medical device, wherein the device assurance indicatorindicates whether the medical device is compatible with a sterilizingcabinet associated with the sterilizing cabinet identifier and asterilization cycle associated with the sterilization cycle type.
 2. Thedevice of claim 1, wherein the device is a sterilizing cabinet; whereinthe communication device is a wireless transceiver configured to beconnected to the sterilization system via a wireless communicationnetwork; wherein the user input comprises a touchscreen and an opticalreader; wherein the identifier is a model number associated with aunique description of the medical device; and wherein the identity isthe unique description of the medical device.
 3. The device of claim 1,wherein the device indicator is a set of device tracking informationreceived from the sterilization system; wherein the set of devicetracking information indicates an in-transit medical device leaving froman origin and having a destination of the device; wherein the set ofmedical device records associate the in-transit medical device with theidentity of the medical device; wherein the processor is furtherconfigured to determine that the medical device is the in-transitmedical device.
 4. The device of claim 1, wherein the user inputcomprises an optical reader that is operable to read data encoded in anoptical identifier; wherein the optical reader is configured to receivethe device indicator after the optical reader reads the opticalidentifier; wherein the set of medical device records associate theoptical identifier with the identity of the medical device.
 5. Thedevice of claim 1, wherein the user input comprises a text input that isoperable to provide a text identifier to the device; wherein the textinput is configured to receive the device indicator as the textidentifier; wherein the set of medical device records associate the textidentifier with the identity of the medical device.
 6. The device ofclaim 1, wherein the processor is further configured to: (i) after theidentity of the medical device is determined, display the identity to auser via the display, (ii) receive an identity response from a user viathe user interface, (iii) where the identity response indicates that theidentity is not correct, provide a manual device input interface via thedisplay, wherein the manual device input interface comprises a set ofprompts for additional information operable by the user to determine anew identity of the medical device, and (iv) configure the at least onerisk mitigation process based upon the new identity instead of theidentity.
 7. The device of claim 1, wherein the processor is furtherconfigured to: (i) determine a set of sterilizing cabinets that arepresent in the sterilization system, (ii) determine, for eachsterilizing cabinet in the set of sterilizing cabinets, a set ofsterilization cycles that each sterilizing cabinet is capable ofperforming, (iii) receive a set of device assurance indicators for eachsterilizing cabinet of the set of sterilizing cabinets from thesterility guide database and determine a set of compatible sterilizationcycle options based upon the set of device assurance indicators, (iv)display the set of compatible sterilization cycle options via thedisplay, (v) receive a selection via the user input, wherein theselection is associated with an option of the set of compatiblesterilization cycle options, and (vi) configure the sterilization cyclebased upon the selection.
 8. The device of claim 1, wherein theprocessor is further configured to, when the device assurance indicatorindicates that the medical device is compatible: (i) indicate via thedisplay that the sterilization cycle is compatible with the medicaldevice, and (ii) upon completion of the sterilization cycle, add acompatibility assured indicator to a cycle result dataset, wherein thecycle result dataset describes the performance of the sterilizationcycle and the compatibility assured indicator indicates that the medicaldevice was compatible with the sterilization cycle.
 9. The device ofclaim 8, wherein the processor is further configured to, when the deviceassurance indicator indicates that the medical device is not assured ascompatible: (i) display via the display a compatibility warning thatindicates the sterilization cycle is not assured as compatible with themedical device, (ii) receive a confirmation via the user input tooverride the compatibility warning and proceed with the sterilizationcycle, (iii) provide an unverified cycle alert via the communicationdevice as an electronic message to one or more recipients, and (iv) uponcompletion of the sterilization cycle, add an assurance warningindicator to a cycle result dataset, wherein the cycle result datasetdescribes the performance of the sterilization cycle and thecompatibility assured indicator indicates that the medical device wasnot assured as compatible with the sterilization cycle.
 10. The deviceof claim 1, wherein the processor is further configured to cause adevice cycle summary interface to display via the display, wherein thedevice cycle summary interface comprises: (A) a sterilizing cabinetdescriptor, (B) a list of cycle results for sterilization cyclesperformed on a sterilizing cabinet associated with the sterilizingcabinet descriptor, and (C) an assurance rate indicating the portion ofthe list of cycle results associated with a compatible device assuranceindicator.
 11. The device of claim 1, wherein the processor is furtherconfigured to cause an instrumentation assurance summary interface todisplay via the display, wherein the instrumentation assurance summaryinterface comprises: (A) a set of medical device descriptors for eachmedical device in service at a location, (B) a set of sterilizingequipment descriptors for sterilizing devices in service at thelocation, (C) a set of assurance descriptors indicating which of thesterilizing devices in service at the location are assured as compatiblefor each medical device in service at the location, and (D) an assurancerate indicating whether any of the medical devices in service at thelocation are not compatible with any sterilizing devices in service atthe location.
 12. The device of claim 11, wherein the instrumentationassurance summary interface further comprises a request assurancefeature associated with an unverified medical device of the set ofmedical device descriptors; wherein the request assurance feature isconfigured to be interacted with via the user interface to cause anelectronic communication to be sent to a recipient associated with thesterility guide database; wherein the electronic communication describesthe unverified medical device and the set of sterilizing equipmentdescriptors.
 13. The device of claim 1, wherein the at least one riskmitigation process comprises an automatic cycle selection, wherein theautomatic cycle selection is configured to cause the processor to: (i)determine an approved cycle configuration based upon the identity of themedical device, and (ii) configure the sterilization cycle based uponthe approved cycle configuration.
 14. The device of claim 13, whereinthe approved cycle configuration is associated with a device assuranceindicator, wherein the device assurance indicator is configured to bereceived from a sterility guide database based upon the identity of themedical device, wherein the device assurance indicator is furtherconfigured to indicate that the medical device is compatible with thesterilization cycle.
 15. A device usable with a sterilization system fora medical device, the device comprising: (a) a processor and a memory;(b) a communication device; (c) a user input; and (d) a display; whereinthe processor is configured to: (i) receive a device indicatorassociated with the medical device, (ii) access a set of medical devicerecords and determine an identity of the medical device based upon anassociation of the device indicator with the set of medical devicerecords, (iii) configure at least one risk mitigation process based uponthe identity of the medical device, (iv) configure a sterilization cycleto be performed on the medical device based upon the at least one riskmitigation process, (v) after the identity of the medical device isdetermined, display the identity to a user via the display, (vi) receivean identity response from a user via the user interface, (vii) where theidentity response indicates that the identity is not correct, provide amanual device input interface via the display, wherein the manual deviceinput interface comprises a set of prompts for additional informationoperable by the user to determine a new identity of the medical device,and (viii) configure the at least one risk mitigation process based uponthe new identity instead of the identity.
 16. The device of claim 15,wherein the device indicator is a set of device tracking informationreceived from the sterilization system; wherein the set of devicetracking information indicates an in-transit medical device leaving froman origin and having a destination of the device; wherein the set ofmedical device records associate the in-transit medical device with theidentity of the medical device; and wherein the processor is furtherconfigured to determine that the medical device is the in-transitmedical device.
 17. The device of claim 15, wherein the at least onerisk mitigation process comprises an automatic cycle selection, whereinthe automatic cycle selection is configured to cause the processor to:(i) determine an approved cycle configuration based upon the identity ofthe medical device, and (ii) configure the sterilization cycle basedupon the approved cycle configuration.
 18. A device usable with asterilization system for a medical device, the device comprising: (a) aprocessor and a memory; (b) a communication device; (c) a user input;and (d) a display; wherein the processor is configured to: (i) receive adevice indicator associated with the medical device, (ii) access a setof medical device records and determine an identity of the medicaldevice based upon an association of the device indicator with the set ofmedical device records, (iii) configure at least one risk mitigationprocess based upon the identity of the medical device, and (iv)configure a sterilization cycle to be performed on the medical devicebased upon the at least one risk mitigation process, wherein the atleast one risk mitigation process comprises an automatic cycleselection, wherein the automatic cycle selection is configured to causethe processor to: (A) determine an approved cycle configuration basedupon the identity of the medical device, (B) configure the sterilizationcycle based upon the approved cycle configuration wherein the approvedcycle configuration is associated with a device assurance indicator,wherein the device assurance indicator is configured to be received froma sterility guide database based upon the identity of the medicaldevice, and wherein the device assurance indicator is further configuredto indicate that the medical device is compatible with the sterilizationcycle.
 19. The device of claim 18, wherein the device indicator is a setof device tracking information received from the sterilization system;wherein the set of device tracking information indicates an in-transitmedical device leaving from an origin and having a destination of thedevice; wherein the set of medical device records associate thein-transit medical device with the identity of the medical device;wherein the processor is further configured to determine that themedical device is the in-transit medical device.
 20. The device of claim18, wherein the processor is further configured to: (i) after theidentity of the medical device is determined, display the identity to auser via the display, (ii) receive an identity response from a user viathe user interface, (iii) where the identity response indicates that theidentity is not correct, provide a manual device input interface via thedisplay, wherein the manual device input interface comprises a set ofprompts for additional information operable by the user to determine anew identity of the medical device, and (iv) configure the at least onerisk mitigation process based upon the new identity instead of theidentity.